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510(k) Data Aggregation

    K Number
    K003078
    Device Name
    MERIT DRAINAGE DEPOT
    Manufacturer
    MERIT MEDICAL SYSTEMS, INC.
    Date Cleared
    2000-12-11

    (69 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    EXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K990428
    Device Name
    DRAINAGE BAG
    Manufacturer
    REMINGTON MEDICAL, INC.
    Date Cleared
    1999-08-12

    (182 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    EXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Drainage Bags are single use and shall be used by a urologist or a gastroenterologist in a healthcare setting to for nephrostomy, biliary, abscess and other drainage collection.
    Device Description
    Drainage Bag
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    K Number
    K980005
    Device Name
    MANAN D BAG
    Manufacturer
    MEDICAL DEVICE TECHNOLOGIES, INC.
    Date Cleared
    1998-01-30

    (28 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    EXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Manan™ D Bag is for nephrostomy, abcess and other drainage collection.
    Device Description
    The Manan D Bag is a 600 ml drainage bag to be used for biliary, nephrostomy and other fluid drainage procedures. The bag has a twist close closure at the bottom for allowing the fluid to drain out. The bag is manufactured from either SP 2255, (an Ethylene Methyl Acrylate Copolymer film) or PVC. The catalog number will be DBAG 600 when Ethylene Methyl Acrylate Copolymer film is used, and DBAG 600V when PVC is used. The bag itself has a backing made from a non-woven polyester. This backing provides comfort for the patient. This backing will be optional on the product. A tube made from silicon is attached to the bag at one end and has a luer lock at the other for attaching to the drainage catheter. The preferred length of this tube is 30 ins. Other lengths between 24 and 42 ins. could possible be used in the future. An adjustable Velcro strap with some elasticity is supplied with the bag so it can be hung about the patient's waist, leg or shoulder.
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    K Number
    K961986
    Device Name
    MANAN D BAG
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1997-03-13

    (296 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    EXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question
    K Number
    K963849
    Device Name
    MANAN D BAG
    Manufacturer
    MANAN MEDICAL PRODUCTS, INC.
    Date Cleared
    1996-12-13

    (79 days)

    Product Code
    EXF
    Regulation Number
    876.5010
    Why did this record match?
    Product Code :

    EXF

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
    Ask a Question

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